Systems for generating image-based measurements during diagnosis

ABSTRACT

Devices, systems, tools and methods are disclosed during diagnosis and treatment of spinal conditions. A cervical plumb line device is disclosed which can be used to produce a measurement of the sagittal vertical axis associated with a target part of a patient&#39;s cervical spinal anatomy from two or more radiographic images. Also disclosed is an apparatus for measuring the angulation of a patient&#39;s spinal anatomy relative to a cervical plumb line which uses a plurality of bolsters. A device that can be used to assist in implantation of an interbody device during spinal fusion device is also disclosed. Systems which produce geometric data describing optimized spinal fusion geometric at a spine level selected to receive spinal fusion.

CROSS-REFERENCE

This application is a divisional application of Ser. No. 15/728,854filed Oct. 10, 2017 which claims the benefit of U.S. ProvisionalApplication No. 62/406,703 filed Oct. 11, 2016, entitled Apparatus andMethods for Generating Image Based Measurements During Diagnosis and62/424,690 filed Nov. 21, 2017, entitled Apparatus and Methods forGenerating Image Based Measurements During Diagnosis which applicationsare incorporated herein by reference.

BACKGROUND

Posterior fusion with traditional impacted devices often requiresstretching of the posterior longitudinal ligaments (PLL) to accommodatethe height of the implant that is being inserted between vertebralbodies of the spine. When the interbody anterior height is within aknown safe range (e.g., less than or equal to PDH_(max)) then PLLdistraction is avoided. In contrast, where the interbody anterior heightbetween adjacent vertebral bodies is uncertain or greater thanPDH_(max), then PLL distraction may be required. For 58% of thedegenerative fusion patient population, posterior access to the spinerequires exceeding the known safe rage of the PLL, thus requiringdistraction. These patients would benefit from lateral or obliquesurgery because PLL stretching could be avoided.

Point loading and compromised arthrodesis may occur when the interbodyand endplates of the vertebral bodies are not flush. Point loading, andpotential subsistence can be avoided by keeping the interbody posteriorheight above the known safe rage of the facets. This can also maximizeingrowth surface area and assure the best contact of the graftendplates.

The anterior longitudinal ligament (ALL) may need to be stretched orreleased during spinal fusion procedures depending on the anteriorheight of the interbody device. ALL stretching is avoided when theanterior height of the interbody device is less than the known saferange of the ALL (e.g., less than the ADH_(max)). In contrast, where theinterbody anterior height between adjacent vertebral bodies is uncertainor greater than ADH_(max), then the ALL may need to be stretched orreleased.

A need exists to be able to acquire image-derived measurements ofsagittal alignment, in particular various plumb line measurementsreferred to as Sagittal Vertical Axis (SVA), from a fluoroscope.Usually, these measurements are acquired via standing full-spine lengthx-ray images of the patient in a standing weight bearing un-assistedposture. To calculate SVA for cervical vertebral bodies, it is necessaryto have images that contain both the sacrum up to C0.

However, if these measurements are to be taken from a fluoroscope, thereare operating restrictions—namely the reduced height that the imageintensifier can rise to a C-arm is parallel to the floor. Lateral viewimages of the cervical spine cannot therefore be taken because the C-armcannot go height enough. What is needed is a fiducial andpatient-mounting device aspect, a plumb line device aspect, and aconnecting arm scaling object aspect and methods. Also what is neededare systems that produce geometric data describing optimized spinalfusion geometry for a spine level selected to receive spinal fusion.What is also needed are systems and methods for measuring angulation ofspinal anatomy relative to a plumb line. Additionally, trial instrumentsfor use in applying force to distraction plates which are appliedagainst vertebral end plates are also needed. Additionally, systems andmethods for producing optimized spinal fusion geometric configurationsand recommendations for interventions are also needed.

SUMMARY

Disclosed are devices, systems, tools and methods for generatingimage-based measurements which can be used during diagnosis. A cervicalplumb line device is disclosed which can be used to produce ameasurement of the sagittal vertical axis associated with a target partof a patient's cervical spinal anatomy from two or more radiographicimages. Also disclosed is an apparatus for measuring the angulation of apatient's spinal anatomy relative to a cervical plumb line which uses aplurality of bolsters. A device that can be used to assist inimplantation of an interbody device during spinal fusion device is alsodisclosed. Systems which produce geometric data describing optimizedspinal fusion geometry at a spine level selected to receive spinalfusion.

An aspect of the disclosure is directed to orthopedic plumb linedevices. Suitable orthopedic plumb line devices comprise: an elongatedfirst radiopaque arm having a first arm end and a second arm end whereinthe first arm end is configurable to engage a surface of a patient; avariable length second radiopaque arm which rotatably extends from thefirst radiopaque arm; a third radiopaque arm having a connection end anda patient contact end connected to the first radiopaque arm at theconnection end at a connection position along a length of the firstradiopaque arm. Plumb line devices can also include, for example,reference markings along a portion of a length of the second radiopaquearm. The reference markings can denote a linear distance from theelongated first radiopaque arm. Additionally, the second radiopaque armcan he detachable and/or extendable. Additionally, in someconfigurations, the second radiopaque. arm can have a weighted end.

Another aspect of the disclosure is directed to methods of imaging apatient. Suitable methods comprise: positioning an orthopedic plumb linedevice adjacent a surface of a patient wherein the orthopedic plumb linedevice comprises an elongated first radiopaque arm having a first armend and a second arm end wherein the first arm end is configurable toengage a surface of a patient, a variable length second radiopaque armwhich rotatably extends from the first radiopaque arm, a thirdradiopaque arm having a connection end and a patient contact endconnected to the first radiopaque arm at the connection end at aconnection position along a length of the first radiopaque arm; taking afirst radiographic image of the patient wherein the first radiographicimage includes a portion of a first target spinal anatomy of the patientand a portion of the orthopedic plumb line; taking a second radiographicimage of the patient while the patient is sitting wherein the secondradiographic image includes a portion of a second target spinal anatomyof the patient and a portion of the orthopedic plumb line; and comparingthe first radiographic image and the second radiographic image; andgenerating a measurement of sagittal vertical axis between the first andsecond target spinal anatomy components. Additionally, the method caninclude the step of extending the second radiopaque arm.

Still another aspect of the disclosure is directed to systems formeasuring an angulation of a spinal anatomy of a patient relative to anorthopedic plumb line. Suitable systems comprise: a patient bolsteringsystem having multiple bolsters which engages the patient dorsally atlumbar spine, and ventrally across the hips and above the knees whichallows the patient to achieve a range of pelvic tilt angles; and aprocessing system to measure a plurality of angles selected from anglesbetween anatomic components, angles between one or more anatomiccomponents and a direction of gravity, and a pelvic tilt angle.Additionally, an orthopedic plumb line device can be included in thesystem. The orthopedic plumb line can allow for a plumb lineradiographic marker to be visible in images taken of the spine, pelvis,and/or extremities, and comprise an elongated first radiopaque armhaving a first arm end and a second arm end wherein the first arm end isconfigurable to engage a surface of a patient, a variable length secondradiopaque arm which rotatably extends from the first radiopaque arm, athird radiopaque arm having a connection end and a patient contact endconnected to the first radiopaque arm at the connection end at aconnection position along a length of the first radiopaque arm. Theplumb line can also be a simple radiographic marker.

Yet another aspect of the disclosure is directed to methods of measuringangulation of a spinal anatomy relative to a plumb line. Suitablemethods comprise: engaging a patient bolstering system having multiplebolsters configured to engage the patient dorsally at lumbar spine, andventrally across the hips and above the knees; positioning the patientat a first position; taking a first radiographic image of the patientwherein the first radiographic image includes a portion of a targetspinal anatomy of the patient and a portion of the orthopedic plumbline; taking a second radiographic image of the patient wherein thesecond radiographic image includes a portion of a target spinal anatomyof the patient and a portion of the orthopedic plumb line; comparing thefirst radiographic image and the second radiographic image; andgenerating a measurement based on the comparison of the firstradiographic image and the second radiographic image. The methods canalso comprise one or more of each of: moving the patient through a rangeof pelvic tilt angles and taking a radiographic image at each newposition; projecting a post-operative pelvic tilt angle from a projectedpost-operative angulation from a plurality of angles selected fromangles between anatomic components, angles between one or more anatomiccomponents and a direction of gravity, and a pelvic tilt angle;determining a direction of gravity within the radiographic images; andgenerating radiographic images that are automatically aligned towards aselected direction of gravity.

Another aspect of the disclosure is directed to trial instruments fororthopedic surgery. Suitable trial instruments comprise an elongatedmember, a rotatable knob at a proximal end of the elongated member: anda pair of distraction plates at a distal end of the elongated memberwherein a position or distraction force of the distraction plates iscontrollable by the rotatable knob. In at least some configurations, thetrial instruments can further comprise reference markings about theelongated member adjacent the rotatable knob. Additionally, the pair ofdistraction plates can have a flat surface. The distraction plates canbe parallel to each other when the distraction plates are extended awayfrom the elongated member, and/or when the distraction plates are in alow-profile pre-deployment configuration. A force application feedbackmechanism can also be provided. A rotatable knob can be used to applyforce to the distraction plates, Additionally, the distraction platescan be connected to the elongated shaft via a connector with a rotationpoint.

Still another aspect of the disclosure is directed to methods of using atrial instrument for orthopedic surgery. Suitable methods comprise:inserting the trial instrument between an endplate of a first vertebralbody and an endplate of a second vertebral body adjacent the firstvertebral body, the trial instrument comprising an elongated member, arotatable knob at a proximal end of the elongated member, and a pair ofdistraction plates at a distal end of the elongated member wherein aposition of the distraction plates is controllable by the rotatableknob, adjusting a distance between the pair of distraction plates;increasing a space between adjacent distraction plates. The trialinstrument can further comprise reference markings about the elongatedmember adjacent the rotatable knob. Additionally, the pair ofdistraction plates can have a flat surface. The method can includeextending the distraction plates away from the elongated member, and/orproviding feedback to a user of the amount of force applied to thedistraction plates. The extraction plates can be rotated about aconnection point during at least some methods.

Another aspect of the disclosure is directed to systems for producinggeometric data describing an optimized spinal fusion geometricconfiguration at a spine level selected to receive spinal fusion, foruse during spine surgery or during pre-operative planning. Suitablesystems comprise a processor wherein the processor is configured to: (a)receive one or more images of a spine wherein the one or more imagesincludes a cervical plumb line device; (b) process the received imagesto derive measurements of one or more of a spinal alignment and a rangeof motion at a spine level selected to receive spinal fusion surgery;and (c) utilize the derived measurements to calculate an optimizedspinal fusion geometric configuration for a target spine level.Additionally, the processor can perform one, or more of each of thefollowing steps: receiving configuration parameters from a user; andanalyzing the calculated geometric configuration and recommending asurgical approach; receiving and processing one or more of non-imagepatient data and additional images.

Yet another aspect of the disclosure is directed to systems forproducing patient specific recommendations for intervention. Suitablesystems comprise a processor configured to: (a) process image-derivedmeasurement data of at least one of spinal alignment, range of motion attarget spine levels adjacent to a spinal fusion spine level measuredacross one or more spinal radiographic images; (b) utilize image-derivedmeasurement data to calculate a measurement of a risk of adjacent leveldisease, and (c) select an intervention from a list of interventionsbased on the calculated measurement of risk. The list of interventionscan further be delimited to, for example, include one or more patientself-directed interventions, include interventions generated via a setof user configured variables that do not vary from patient to patient,include interventions selected based on a rationale of avoiding ordelaying a progressions of adjacent level disease, and include one ormore of: activity reduction, modification or substitution; weight loss;physical therapy focused on core/neck strength; physical therapy focusedon addressing pelvic anteversion or retroversion; and interventions toaddress functional anomalies at adjacent levels. Additionally, the datareceived may be either at a single time point or may include multipletime points, and in the case of multiple time points the image-derivedmeasurements are further delimited to include an analysis of thedifference in measurements as taken between two or more time points.

INCORPORATION BY REFERENCE

All publications, patents, and patent applications mentioned in thisspecification are herein incorporated by reference to the same extent asif each individual publication, patent, or patent application wasspecifically and individually indicated to be incorporated by reference.References include:

-   -   U.S. Pat. No. 7,502,641 B2 issued Mar. 10, 2009 to Breen for        Method for imaging the relative motion of skeletal segments;    -   U.S. Pat. No. 8,676,293 B2 issued Mar. 18, 2014 to Breen et al.        for Devices, systems and methods for measuring and evaluating        the motion and function of joint structures and associated        muscles, determining suitability for orthopedic intervention,        and evaluating efficacy of orthopedic intervention;    -   U.S. Pat. No. 8,777,878 B2 issued Jul. 15 2014, to Deitz for        Devices, systems and methods for measuring and evaluating the        motion and function of joints and associated muscles;    -   U.S. Pat. No. 9,138,163 B2 issued Sep. 22, 2015 to Deitz for        Systems and devices for an integrated imaging system with        real-time feedback loop and methods therefor; and    -   U.S. Pat. No. 9,277,879 B2 issued Mar. 8, 2016 to Deitz for        Systems and devices for an integrated imaging system with        real-time feedback loops and methods therefor;    -   US 2016/0235479 A1 published Aug. 18, 2016 to Mosnier et al.,        for Method making it possible to produce the ideal curvature of        a rod of vertebral osteosynthesis material designed to support a        patient vertebral column;    -   US 2016/0210374 A1 published Jul. 21, 2016 to Mosnier, et al.        for Method making it possible to produce the ideal curvature of        a rod of vertebral osteosynthesis material designed to support a        patient's vertebral column;    -   WO2015/040552 A1 published Mar. 26, 2015 to Mosnier et al. for        Method making it possible to produce the ideal curvature of a        rod of vertebral osteosynthesis material designed to support a        patient vertebral column; and    -   WO2015/056131 A1 published Apr. 23, 2015 to Mosnier et al. for        Method making it possible to produce the ideal curvature of a        rod of vertebral osteosynthesis material designed to support a        patient's vertebral column.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. A better understanding of the features andadvantages of the present invention will be obtained by reference to thefollowing detailed description that sets forth illustrative embodiments,in which the principles of the invention are utilized, and theaccompanying drawings of which:

FIG. 1A is a lateral view of a normal human spinal column;

FIG. 1B illustrates a human body with the planes of the body identified;

FIGS. 2A-B illustrate a seated view of a patient with cervical anatomyand standing view of a patient with sacral anatomy with a cervical plumbline device associated with the patient;

FIGS. 3A-B illustrate a portion of an image illustrating the cervicalanatomy (FIG. 3A) and the sacral anatomy (FIG. 3B) with the displacementmeasured;

FIGS. 4A-C illustrate a patient in a normal upright position (FIG. 4A),a bent knee upright standing position (FIG. 4B), and a spinal extensionupright standing position (FIG. 4C) with the bolster connection points;

FIG. 5 is a flow diagram illustrating steps for positioning a patient,performing a range of knee bending and spinal extension angles whichresults in projected pelvic angles;

FIG. 6 illustrates a trial instrument;

FIGS. 7A-D illustrates additional details and variations of the trialinstrument of FIG. 6 ;

FIG. 8 illustrates geometric boundaries for a patient;

FIG. 9 illustrates patient specific geometric boundaries for a fusionconstruct that incorporates safe and non-injurious operating ranges forthe ALL, PLL and facets;

FIG. 10 illustrates current fluoro capture vs. target constructestablished for the patient; and

FIG. 11 is a flow diagram of processes for disease management.

DETAILED DESCRIPTION Acronyms

ADH—Anterior (vertebral) Disc Height; ALD—Adjacent Level Disease;ALL—Anterior Longitudinal Ligaments; API—Application Program Interface;CPU—Computer Processing Unit; LL—Lumbar Lordosis; MID—Millimeters ofDirect Compression; MLO—Millimeters of Listhetic Offset; PDA—PersonalDigital Assistant; PDH—Posterior (vertebral) Disc Height; PI—PelvicIncidence; PLL—Posterior Longitudinal Ligaments; RAM—Random AccessMemory; ROM—Read Only Memory; SMS—Short Message Service; SVA—SagittalVertical Axis; and TCA—Target Construct Achievable.

Anatomical Background

FIG. 1A illustrates the human spinal column 10 which is comprised of aseries of thirty-three stacked vertebrae 12 divided into five regions.The cervical region includes seven vertebrae, known as C1-C7. Thethoracic region includes twelve vertebrae, known as T1-T12. The lumbarregion contains five vertebrae, known as L1-L5. The sacral region iscomprised of five fused vertebrae, known as S1-S5, while the coccygealregion contains four fused vertebrae, known as Co1-Co4. The spine hasregions that have an inward curvature (lordosis), e.g., the lumbar andcervical regions, and an outward (convex) curvature (kyphosis), e.g., inthe thoracic and sacral regions.

In order to understand the configurability, adaptability, andoperational aspects of the invention disclosed herein, it is helpful tounderstand the anatomical references of the body 50 with respect towhich the position and operation of the devices, and components thereof,are described. FIG. 1B illustrates an overview of a patient 20 of threeanatomical planes generally used in anatomy to describe the human bodyand structure within the human body. The three anatomical planes are:the axial plane 52, the sagittal plane 54 and the coronal plane 56.Additionally, devices and the operation of devices and tools may bebetter understood with respect to the caudad 60 direction and/or thecephalad direction 62. Devices and tools can be positioned dorsally 70(or posteriorly) such that the placement or operation of the device istoward the back or rear of the body. Alternatively, devices can bepositioned ventrally 71 (or anteriorly) such that the placement oroperation of the device is toward the front of the body. Variousembodiments of the devices, systems and tools of the present inventionmay be configurable and variable with respect to a single anatomicalplane or with respect to two or more anatomical planes. For example, asubject or a feature of the device may be described as lying within andhaving adaptability or operability in relation to a single plane. Adevice may be positioned in a desired location relative to a sagittalplane and may be moveable between a number of adaptable positions orwithin a range of positions.

A variety of users can use the devices, systems and methods describedherein. To distinguish between pre-operative, operative, andpost-operative use or application, surgical user has been used. However,as will be appreciated by those skilled in the art, the surgical usercan be the surgeon or anyone who assists the surgeon during the surgicalprocess at any time in the work flow, and should not be consideredlimiting.

Cervical Plumb Line Devices

FIGS. 2A-B illustrate a seated view of a patient 20 with portions of thecervical anatomy (specifically vertebral bodies C6 and C7 of the spine)within an imaging field of view 250. A cervical plumb line device is 200shown at least partially within the imaging field of view 250 andengaging an exterior dorsal surface of the patient 20 approximately atthe vertebral bodies C6 and C7. The fiducial plumb line device 200 has afirst radiopaque arm 210 that extends substantially perpendicularly froma dorsal surface of the patient. A second radiopaque arm 220 engages thefirst radiopaque arm 210 along its length and is angled towards thedorsal surface of the patient 20 below the position where the secondradiopaque arm 220 engages the dorsal surface of the patient 20. A thirdradiopaque arm 230 is connected to the first radiopaque arm 210 at anend opposite the end where the first radiopaque arm 210 engages thepatient 20. The third radiopaque arm 230 is retractable, thus allowingit to achieve varying lengths in use. Turning to FIG. 2B, a standingview of a patient 20 with sacral anatomy illustrated is provided. Inaddition to showing the C6 and C7 vertebra, the S1 vertebra is alsoillustrated. The cervical plumb line device illustrated in FIG. 2A isalso shown associated with the patient. In this configuration, becausethe patient is standing the third radiopaque arm 230 is extended.Additionally, reference markings 232 can be provided on the thirdradiopaque arm which provide size information in the resulting images.The size of the field need not change between the views of FIG. 2A andFIG. 2B, and will typically be the same.

FIGS. 3A-B illustrate a portion of the resulting image of the cervicalanatomy (FIG. 3A) and the sacral anatomy (FIG. 3B) with the displacementmeasured resulting from using the device in FIGS. 2A-B. Portions of thefiducial plumb line device 200 (first radiopaque arm 210, and secondradiopaque arm 220) are visible within the imaging field of view 350 inFIG. 3A as well as the cervical anatomy C6 and C7. The displacement dbetween the cervical plumb line and the cervical anatomy can be measuredfrom the image. As shown in FIG. 3B, the position of the S1 vertebra canalso be detected using the reference markings 232 on the thirdradiopaque arm 330 in an extended mode.

As shown in FIGS. 2A-B, the cervical plumb line device has three maincomponents: A fiducial and patient-mounting member (the first radiopaquearm 210 can also include a fiducial marker), a plumb line member (thethird radiopaque arm 230), and a connecting arm scaling member (thesecond radiopaque arm 220).

The fiducial plumb line device 200 can provide a fiducial marker thatappears in the image of the patient that is taken for reference. Thefiducial plumb line device 200 is, for example, a shoulder or neckmounted component that is puts a radiopaque fiducial marker in afluoroscopic lateral image of, for example, the C6 or C7 cervical regionof the spine, such that the distance between the C6 or C7 vertebra andthe fiducial marker can be calculated. As will be appreciated by thoseskilled in the art, the fiducial marker can be a ball or some otherobject mounted on a connecting arm to a patient facing mountingmechanism that includes pads, bolsters, straps, and other mechanisms forphysically positioning the fiducial marker fixedly with respect to thepatient such that the relative distance between the fiducial marker and,for example, the C6 or C7 vertebra cannot change while the cervicalplumb line member is mounted, and such that the connecting arm ispositioned as close to perpendicular in the coronal plane as possible(so that length distortion in the sagittal plane is minimized). Thefiducial marker could serve as a ball joint for the plumb line device.

The plumb line device can have a variable length metal (or radiopaque)arm that hangs rotatably from the fiducial marker as illustrated inFIGS. 2A-B. The plum line device for example could be a telescopingmetal member, such as a ruler, or some other object of variable length.In operation, the plumb line can be disconnectable from the fiducialpatient mounting. The plumb line member can have radiopaque lengthmarkers, so that the length of the fiducial can be read in the resultinglateral view fluoro images. Additionally, the plumb line member can beweighted at the end opposite the connection end to facilitate orientingthe plumb member so that it is perpendicular to the floor. The plumbline member can rotate about a connection point to swing freely andalign itself to the direction of gravity (i.e., perpendicular to thefloor).

The third aspect of the cervical plumb line device is the connecting armscaling object. The connecting arm is a scaling object of a fixed lineardimension that, when viewed radiographically, can be calibrated toaccount for out-of-plane affects that can add length distortion tosagittal plane distance measurements taken from the fluorographic image.This scaling object may be linear only, or may be bi-linear, where it iscomprised of orthogonal line segments that would be visible in lateralimages.

In operation of the cervical plumb line device, there is typically athree step process:

(1) mount the cervical plumb line device and take a first seatedcervical image of the patient with the cervical plumb line device (thevertical plumb-line member may be in either a retracted or extendedposition), (2) stand the patient up, and adjust the length of the plumbline until it freely hangs and is visible in a field of view in which itis also possible to image the posterior edge of the sacrum and take asecond image, then (3) perform image processing on the first and secondimages. The imagine processing would include: (3a) in the first image,markup of the four corners of the lateral projection of C6, C7, or anyother vertebral body of interest, then measure the exact displacementbetween the back of the relevant anatomy (e.g. C6 and C7) and thefiducial object and point of origin for the plumb line; (3b) use of thesecond image to measure the exact displacement between the back of thesacrum and the plumb line; and (3c) combine these two images to create areconstructed by reading the length of the telescoping member and byaligning the plumb lines across both images to derive the relevant SVAmeasurements.

Use of a Patient Handling Device and Analytic Methods to Estimate aDegree of Pelvic Anteversion and Retroversion

Another aspect of the disclosure relates to the use of a patienthandling device to achieve a measurement of pelvic ante-retroversion.

FIGS. 4A-C illustrate a patient 20 in a normal upright position (FIG.4A), a bent knee upright standing position (FIG. 4B), and a spinalextension upright standing position (FIG. 4C) with the bolsterconnection points. A first connection point 410 is positioned for thepatient 20 to engage ventrally with their arms or hands. A secondconnection point 420 is positioned to engage the patient 20 dorsally atthe sacral curve of the spine. A third connection point 430 engages thepatient 20 ventrally above the knee. A fourth connection point 440engages the patient 20 ventrally at the hips. For reference the hip bone30 is illustrated. The patient handling devices of FIGS. 4A-C are usedto assure a known controlled amount of knee or hip flexion by thepatient. The patient handling devices also facilitate achieving a targetposture, with assistance and pelvic bolstering by the patient handlingdevice. The target posture approximates what the patient would strive toachieve without assistance. One skilled in the art would appreciate thatthere could be numerous combinations of these four types of bolsters,including configurations wherein only one, two, or three of the fourbolsters illustrated are required. Additionally, a plumb line device,such as described in FIGS. 2A-B, could be mounted to the patient's hip,adjusted in its sagittal depth, to provide an indicator of an optimalposition of the pelvis relative to the ankles and knees of the patient.A plumb line device could also be positioned to assure that the knee andankle are optimally aligned. Positioning a plumb line device in any ofthese positions would have the effect of allowing for precise motion ofthe pelvis relative to the knees and ankles to achieve a physiologicallyoptimized plumb line. In some configurations, the plumb line can also bea simple radiographic marker.

Patient bolsters could be used, such as bars and handles illustrated inFIGS. 4A-C, to allow the patient to support themselves in a full neutralupright posture. The bolsters could additionally have other mechanismsto achieve a specific level of anteversion or retroversion of the hips.Any number of bolstering schemes could be provided, but generally theone that is preferred is the one that would be the “base” of a balancedspine. For this purpose—determining the ideal angle of pelvic tilt in acorrected spine, in certain therapies (see WO2015/040552 A1 andWO2015/056131 A1) there is typically a manual correction to pelvic tiltto account for post-operative decompensation, with such manualcorrections being used to project a post-operative pelvic tilt, which inturn can be used to project any number of post-operative sagittalalignment measurements.

In use, the patient could be imaged in an uncontrolled manner at a firsttime, and in a controlled manner using the bolster device of FIG. 4 at asecond time—either before or after the first time to providenon-overlapping images. A plumb line indicator device, such as shown inFIGS. 2A-B, can also be used within the field of view of each of theimages at the target location. Alternatively, the plumb line could besecured directly from the imaging equipment (if, for example, themodality incorporates a millimeter calibration functionality After thedesired images are acquired, an expected lordosis can be determined anda sagittal alignment correction can be added. The expected lordosis andsagittal alignment correction could be projected such that apost-operative lordosis and correction could result in a set of sagittalalignment measurements that more closely approximate ranges observed inasymptomatic subjects.

The correction factor can be used to project a post-operative sagittalalignment for a spine surgery patient. In constructing the SVA, thepelvic tilt can be set to a value measured from the apparatus, then thecorrected spine is “connected” to the sacrum, then the SVA targets canbe made to determine overall correction targets.

Other mechanisms for determining overall correction targets also includethe incorporation of automated diagnostics that detect and measurevertebral wedge fractures. Correction targets could be added to, forexample for any fracture that occurs before the inflection point betweenlordosis and kyphosis (the thoracic apex) into lumbar correction goals,and also into kyphosis goals for the spine segment superior of thethoracic apex.

As shown in FIG. 5 , the patient is positioned, an image is captured,and data is derived regarding pelvic tilt and spinal sagittal alignment510. This process can be repeated for a range of knee bending angles520. Additionally, or in the alternative the process can be repeated fora range of spinal extension angles 530. The output of the processprovides the ability to project pelvic angles as an output based on aninput spinal sagittal alignment 540.

Specialized Trialing Instrument for use in the Implantation of SpinalInterbody Devices.

Also disclosed is a trial instrument, usable in spine fusion surgery.The trial instrument is illustrated in FIGS. 6 and 7A-D. This trialinstrument 600 has a proximal user-end 620, and a distal implant end.The trial instrument 600 has a shaft 622 which has the proximal user-end620 at one end (e.g., handle) and the tool at the other end. As will beappreciated by those skilled in the art, there will be differentconfigurations of the trial instrument for lateral, oblique, andposterior-lateral, and trans-foramina interbody fusion procedures. Usingthe trial instrument can minimize tissue disruption to the end plates ofthe vertebral bodies and improve surgical work flow. For example, whenthe distal end of the trial instrument is closed it can have a width ofabout 8 mm, when it is opened it can have a width of about 16 mm. Usingthe trial instrument avoids disrupting the vertebral endplates multipletimes.

The distal end of the trial instrument 600 has two distracting plates630, which are shown perpendicular to one another, to which can beapplied a controlled and measurable distracting force. The distractingplates 630 are moveable with respect to the shaft 622 and are connectedvia an arm 640 and a hinge 650. On the proximal user end, is the abilityto control the applied force and/or displacement, by use of a controller610. A suitable controller 610 includes, for example, a rotating knobwhich “clicks” when a pre-specified torque or force is achieved at thedistal end between the distracting plates. Alternatively, a strain gaugecan be provided to allow the surgical user to see the total displacementbetween the distracting plates 630. Measurements of force and/ordisplacement (from the gauges) could additionally be shown physicallyvia a gauge that is radiopaque and readable via the radiographic imagein some configuration. One skilled in the art would also appreciate thatthe displacement and/or force measurements could be transmitted viaelectronic sensors and communicated via suitable wired or wirelesselectronics.

FIG. 7A is a close-up of the proximal end of the trial instrument 700showing the rotatable knob and which has a pointer to illustrate theforce applied at the distal end. The controller 710 can includereference markings 712 to provide the surgical user feedback to theamount of force applied and/or the amount of displacement between theend plates 730. The handle 720 can have surface treatment, asillustrated, to ensure the surgical user has a solid grip. The handle720 can be cylindrical, as shown, or can have wells on a surface tocorrespond to a surgical user's finger placement. The handle 720 ispositioned at a proximal end of an elongated shaft 722. FIG. 7B is aclose-up of the distal end of the trial instrument 700, where the trialinstrument is positioned between two end plates of vertebral bodies C6and C7. The distracting end plates 730 engage the trial instrument viarotatable arms 740 which have a hinged rotation point 750. Thedistracting end plates 730 can remain parallel to one another during useor can be non-parallel.

The distal end configuration illustrated in FIGS. 7C-D, illustratesdistracting end plates 730 that are positioned at the distal end of theelongated shaft 722. The distracting end plates 730 are controllable bya mechanism that allows for a controlled displacement between theplates, such as a scissor jack mechanism 760 or scissor lift. Thescissor jack mechanism 760 is a pantograph which is a mechanical linkageconnected in a manner based on parallelograms. The scissor jackmechanism 760 creates a foldable support that has a plurality of members762, 764 which are rotatable about a rotation point 780 and which form across-crossed pattern when viewed from the side. The scissor jackmechanism 760 functions like a spring where the elevation or displacingmotion of the two distracting end plates 730 takes place due to theapplication of pressure by the surgical user at the proximal handle. Oneskilled in the art would recognize that any number of other mechanicaldistraction mechanisms could be adopted to accomplish a controlledand/or measured displacement of the end plates 730 without departingfrom the scope of the disclosure.

In use, the endplate facing surface of the distal end of the trialinstrument can pivot freely about the rotation point and assume a rangeof angles so that the trial instrument can assume the angle between theendplates. The use of the trial instrument 700 facilitates avoidingposterior osteotomies, ALL releases and ALL resections. Additionally,use of the trial instrument avoids unnecessary distraction and/orresection of the anterior and posterior ligaments. Use of the trialinstrument avoids distracting the PLL during insertion of posteriordevices and can precisely control the amount of ALL stretching, addingonly the amount required and avoiding over-stretching. Use of the trialinstrument also avoid stress loading on the endplates of the vertebralbodies of the spinal level and the potential resulting destruction ofcortical tissue caused by subsidence (which can occur when implants areused that have undersized PDH). Additionally, use of the device avoidserrors in pedicle screw placement when surgical navigation/robotics areused. Moreover, distraction and compression of the spinal level viaposterior instrumentation can be avoided unless necessary. As will beappreciated by those skilled in the art, a properly fitted fusion deviceshould not require posterior adjustments.

When used for anterior distraction, the trial instrument avoidsdisrupting the posterior side. This is because posterior targets arebased on how low, not how high, the posterior side can go. Distractionor compression, if required, can be added when adding posteriorinstrumentation. The trial instrument also has a gauge which can reportADH, then, in the case that an intra-operative confirmation system isbeing used, the capture/register can be skipped and the ADH can simplybe manually input into the system. This allows all key parameters to becalculated while avoiding the capture/register workflow that wouldotherwise be required if the instrument were used in combination with anintra-operative confirmation system.

The trial instrument allows the surgical user to start with a minimumlevel of tissue disruption, and then assess intraoperative % TCA, °PI−LL and MID to determine if further disruption is required. Thesurgical user starts with a minimum level of ALL and PLL disruption. Adetermination of the minimum ALL tension is made, then the interbody isexpanded to a minimum ALL tension. Posterior instrumentation, setscrews, and rods are positioned but not locked. One or moreintraoperative confirmations is performed, e.g., by obtaining afluorographic shot at four point registration to determine % TCA, °PI−LL, MID and MLO. From there a decision is made as to whether theminimum disruption was enough, if not then further distraction,compression or reduction is made followed by an updated confirmation.

Distraction using the trial instrument achieves the following: (1) itallows for distraction of the anterior side of the vertebral disc spaceonly, (2) it has a variable displacement mechanism, such as a scissorjack shown in FIG. 7C-D, to provide a controlled displacement betweenthe anterior side of a vertebral endplate, (3) the distraction platesare mountable via a mechanism that lets the distraction plates assumeany angle relative to each other, so that there is maximum contactbetween the vertebral body endplates and the distraction plates; and (4)the distraction plates can be radio opaque, while other components ofthe trial instrument are radiolucent.

The trial instrument output can be used to input directly into anintra-operative navigation system, for the purpose of providing thesurgical user specific instructions and surgical parameters, such aswhat size and type of interbody device to select, or how much furtheradjustment needs to be done to the fusion construct to achieve thetarget geometry.

By connecting the trial instrument directly to an intra-operativenavigation system, the trial instrument can be used to provide a directdata link via a wireless or wire based connection. The trial couldprovide the information to the computer to measure the specificforce-displacement curve for a patient's ALL (in other embodiments, itcould be directed at measuring the PLL and the device as a whole couldbe adapted for this purpose). Knowing this force, it would be possibleto determine a projected maximum range, possibly by looking up referencedata taken from in vitro experimentation. There could be other featuresenabled by having this data to support a more minimally invasiveapproach to fusion surgery, such as linking the instrument toinformation systems that can provide optimal configuration parameters(in terms of force and/or displacement measurements, interbody devicesizes, interbody device selection, and the selection, sizing,configuration, and other parameters related to the implantation ofposterior instrumentation during spinal fusion surgery). Having atorque-controlled or force controlled mechanism could allow theintra-operative system to determine the ideal amount of force, possiblyby consulting information about the patient's bone density, demonstratedrange of motion at that level, and/or data from in vitro studies, andthen have the instrument automatically set to allow only up to thespecified level of distracting force.

As shown in FIG. 8 , two vertebral end plates 810, 810′ are shown. Thespace between the end plates is where an intervertebral disc (orintervertebral microcartilage) is positioned. Disc height, expectedlordosis, and listhetic offset can be derived from neighboring vertebrallevels. A target construct can be automatically rendered by the systemfor each 1-level and 2-level fusion scenarios. The height at the leftside 840 from upper end plate 810 to lower end plate 810′ can be, forexample, 23.5 mm, while the height at the right side 850 can be 10.1 mm.A 1.1 mm distance 860 between an edge of the upper end plate 810 and anedge of the lower end plate 810′. A post-operative kyphosis margin 820can be determined, along with a sagittal alignment correction 830. Thepost-operative kyphosis margin 820 can be, for example, 4°, and thesagittal alignment correction 830 can be, for example, 5°. In thisscenario, the overall expected segmental lordosis is about 12°. Theexpected lordosis can be set based on user-selected distributionfunction. A sagittal alignment correction can be added in the differencebetween PI−LL and +/−10.

FIG. 9 illustrates safe dimensions that are patient-specific boundariesfor a fusion construct that represents safe and non-injurious operatingranges for the ALL, PLL and facets based on two vertebral end plates areshown 910, 910′ in an image. For reference the facets 16 and anteriorlongitudinal ligament 14 is shown, along with the posterior longitudinalligament 18. The target illustrated in FIG. 9 is 21°, and the ALL_(max)range 970 is shown in the left side, while the PLL_(max) range 980 andFacet_(min) ranges are shown on the right. Overlaying known safe dataonto the target construct allows the surgical user to know if and howmuch disruption of the vertebral endplates is required. Thepost-operative kyphosis margin 920 can be determined, along with asagittal alignment correction 930.

The % TCA, or percent target construct achievable (TCA), distills thedecision-making process down to a number that can assist the surgicaluser in managing difficult trade off decisions. For any given fusionconstruct, % TCA is the percentage that the construct achieves thetarget lordosis values.

% TCA=[Lordosis_(Current)]/[Lordosis_(Target)]  (EQ. 1)

The pelvic incidence minus the lumbar lordosis measurement for theconstruction is the PI−LL. The % TCA and PI−LL analysis provides anassessment of the trade-off between the future re-operation risk (ALDrisk) vs. the risk of more tissue disruption during the currentprocedure, both pre-operatively and intra-operatively. For example, themost minimally invasive approach achieves a 65% TCA and 13° PI−LL. Fromthese numbers, the surgical user can determine whether this is enoughcorrection for the patient, or whether more disruptive options arepreferable to achieve greater correction. Will this patient be able totoleration a re-operation in 5-15 years? Is the patient likely to be tooold or too infirm for another operation? What type of pain did thepatient complain of? What matters most to the patient—minimal disruptionor minimal risk of re-operation?

The millimeters of direct compression (MID) represents that the size ofthe increase in posterior disc height (PDH) above the minimum valueobserved during the functional testing. MLO is the millimeters oflisthetic offset. A given fusion construct can be characterized by thefollowing:

MID=[PDH_(Current)]—[PDH_(min)]  (Eq. 2)

MLO=[Offset_(Current)]  (Eq. 3)

Comparing the percentage of TCA and the MID enables an assessment of thetrade-off between the future re-operation risk (e.g. risk of adjacentspinal level disease, ALD risk) versus the competing goal of achievingthe desired level of indirect decompression. MLO measurements are usefulin finalizing the pedicle screw depth and/or screw-rod connections.

Including PDH targets when sizing implants maximizes the surface area ofthe implant/vertebral endplate interface to maximize arthrodesis (e.g.,surgical immobilization of the adjacent vertebral bodies by bonyingrowth). Additionally, selection of devices can be optimized to avoidcompromised ingrowth due to the reduced ingrowth surface area. The useof non-expandable devices can be preferred over expandable devices toavoid such compromised ingrowth. Controlling the amount ofpost-operative tension on the ALL by determining optimal tensionpre-operatively or operatively can assure sufficient compression topromote arthrodesis while avoiding over-distraction between thevertebral bodies. Additionally, minimized disruption of the endplatesthrough repetitive or high-force trailing preserves a maximum amount ofhealthy tissue to promote ingrowth.

Indirect decompression increases posterior disc height which reducessegmental lordosis. Indirect decompression is often a primary objectivein degenerative fusion. Achieving an indirect compression, however, canbe achieved at the expense of lordosis—assuming the ALL remains intact.Consequently, surgeons balance lordosis targets against posterior discheight targets.

TABLE 1 Pre-Operative Decision Support Scenario 1: Scenario 2: Scenario3: Maximum Patient Average Maximum Indirect Lordosis PDH DecompressionLordosis Possible 16° 11°  8° Target Lordosis 21° 21° 21° % TCA 77% 54%36% (16/21) (11/21) (8/21) °PI-LL 13° 16° 19° MID 0 mm +3.2 mm +5.5 mm

Table 1 provides an example where % TCA, PI−LL and MID are assessedagainst each other in selecting a surgical approach. Based on theresults in the example, a decision process can be performed as follows:

If the % TCA is too low and the PI−LL are too high, consider a 2 vs. 1level fusion; consider posterior osteotomy; consider anterior release.

If the % TCA is high enough and PI−LL is low enough, no need to considera more aggressive surgical plan. In this scenario, if lordosis is thepriority, select maximum lordosis scenario (77% TCA). If decompressionif the priority, select the maximum indirect decompression scenario (36%TCA) and +5.5 MID.

FIG. 10 illustrates a fluoro capture versus a target construct. Twovertebra, L4/L5 are illustrated as an example. The fluoro capture 1120of L4, is offset from the target construct 1112 of L4 relative to thetarget construct 1110 of L5. The target construct 1112 of L4 has anoffset 1130 of 4° to the position of the fluoro capture 1120. The degreeof offset 1130 is also reflected in a mechanical shift of the positionof the vertebral facing end plates. The L5 endplate 1114 should rotate4° from the captured L4 endplate 1116, to target L4 endplate 1115. Thisis achieved with a shift along the x-axis of −1.4 mm, a shift on they-axis at a first position of the x-axis 1134 of 15.2 mm and a shift onthe y-axis at a second position of the x-axis 1136 of 4.1 mm.

The process for analyzing lateral and oblique devices intraoperativelyincludes, determining and identifying which spinal levels are to bemodified, where each spinal level is a pair of vertebral bodies. So, forexample, spinal level 1 could be L4/L5 and spinal level 2 could beL5/S1. Next the surgical user accesses and prepares the disc spacebetween the facing end plates of each selected spinal level and insertsthe trial device of FIGS. 2, 6 and 7 . The trial device measures ADHand, for example, anterior distraction (for lateral/oblique impacteddevices), the distance between the facing end plates of the vertebralbodies of the selected spinal level can be expanded as desired. Thetrial device can be distracted to achieve a desired tension. Data can becaptured and registered for a tension to produce a percentage lordosistarget achieved, specify an optimal implant based on the target PDH andADH as measured by using the trial device. The process of distractingthe vertebral bodies of the spinal level and capturing and analyzingdata can be repeated and iterated as necessary to optimize the resultsachieved. This provides essentially real-time iteration and optimizationof the sizing process to ensure the best results are achieved aftersurgery. Once the distraction, capture, registering, and data analysissteps are completed, and a device is selected the selected device isimplanted. Following implantation, additional capturing and registeringof data and adjusting of the construct with posterior instrumentationcan be performed. This post-implantation process looks at the percentlordosis target achieved and the amount of offset of the target.Navigation and robotics can be used for pedicle screw placement. Theworkflow for lateral, oblique and posterior intra-operative andpost-operative is largely the same. The pre-operative decisions aredifferent based on the drivers that depend on the surgical approach tobe taken.

The process for analyzing ADH and PDH adjustable devicesintraoperatively includes, determining and identifying which spinallevels are to be modified, where each spinal level is a pair ofvertebral bodies. So, for example, spinal level 1 could be L4/L5 andspinal level 2 could be L5/S1. Thereafter, the expandable implant isinserted. The posterior side of the device is expanded to the target mmfor the PDH. For this step, implants with independent ADH and PDHadjustability plus instruments that can achieve a specific posteriordisplacement in mm is optimal. The anterior side of the device isexpanded to a minimum target for ALL tension. At this point,determination of how close the spacing between the endplates of thevertebral bodies of the spinal level is to the target extraction isdetermined. Once the device is implanted and the height is adjusted, theresults are captured and registered and a determination of percentage oflordosis to the target has been achieved, and the overall offset to thetarget. Anterior and/or posterior expansion adjustments can be made asneeded. Additional adjustments of the construct with the posteriorinstrumentation can also be made. The workflow for lateral, oblique andposterior intra-operative and post-operative is largely the same.

In all of the above steps, the computer would be instrumental inassessing a current captured and registered vertebral body geometry tothat of the target. This involves the application of complex geometricformulae to the relative position data from the capture/register processto derive easy-to-use measurements of the additional geometricadjustments to the fusion construct required to achieve the targetgeometric configuration. These complex geometric formulae include: (1)comparing four point templates for vertebral body endplates associatedwith a target geometric configuration to the four point templates forvertebral body endplates as taken from a “capture/register” processexecuted by an intra-operative surgical execution system, (2) based onthis comparison, generating specific instructions as to the amount ofrotation, anterior disc height, posterior disc height, or listheticoffset that would need to be added to the fusion construct to achievethe target. The geometric formulae that are used would compare thesuperior edge of the inferior vertebral body of a spinal level to theinferior edge of the superior vertebral body of the level, and derivesmeasurements of angulation (lordosis), ADH, PDH, and listhetic offset ofthe level from the “capture/register” process, then calculates thedifferences relative to a target configuration. Instructions to the userin terms of additional geometric changes to make could be expressed interms of additional lordosis, ADH, PDH, and/or listhetic offset to addto the fusion construct.

As an example of the complex geometric formula, assume thatP1(x,y)_(Ant/Sup), P1(x,y)_(Post/Sup), P1(x,y)_(Ant/Inf), andP1(x,y)_(Post/Inf) refers to the four corner points of a first vertebralbody template (the subscripts denote which corner point, anteriorsuperior, posterior superior, anterior inferior, and anterior superior,respectively). Further assume that P2(x,y)_(Ant/Sup),P2(x,y)_(Post/Sup), P2(x,y)_(Ant/Inf), and P2(x,y)_(Post/Inf) refers tothe four corner points of a second vertebral body template. If the firsttemplate corresponds to a target configuration, and the second templaterefers to the location of a capture/register process doneintra-operatively, then the amount of additional lordosis required toachieve the target would be calculated by the formula:

2*Arctangent[(P2(x)_(Ant/Inf)−P1(x)_(Post/Inf))/(P2(y)_(Ant/Inf)−P1(y)_(Post/Inf))*0.5]

For any of the procedures, post-operative review can be performed atsuitable intervals: e.g., 6 months, 9, months, 12 months, 18 months, 24months, and so on. A detection of radiographic evidence of adjacentspinal level disease (ALD) based on changes from pre-operative valuescan be detected. The radiographic evidence precedes clinical evidenceand can be used for patient intervention. From the data, iterationand/or escalation of treatment can be recommended depending on thesymptoms and the extent of the radiographic progression. Data andrecommendations can be provided to the surgical user to manage ALD risk.Custom reports can be generated which focus on managing ALD risks,coupled with direct-to-patient disease management offerings withinterventions to delay or avoid re-operation. Other recommendations,such as regenerative therapy, can also be made. Recommendations foradditional testing or more frequent testing can be provided to allow formonitoring further progression based on post-operative data.

The systems and devices allow for assessing pre-operative risk of ALDand minimizing the ALD risk by adding lordotic corrections to the spinefusion constructs. Balancing of the lordosis correction goals can alsobe balanced against other surgical objectives and imperatives.Additionally, early ALD monitoring and detection is enabled. In someconfigurations, a direct-to-patient, disease management system can beused to empower patients with recommendations to proactively avoid ordelay ALD progression and re-operation. Recommendations include, forexample, reducing activity, modifying activity, substituting activity,weight loss, physical therapy, exercise or chiropractic interventionfocused on improving core and/or neck strength, and physical therapy,exercise or chiropractic intervention focused on improving pelvicanteversion or retroversion.

FIG. 11 illustrates a process for disease management for ALD as achronic condition. Preliminarily, pre-operative baseline data atadjacent spinal levels is acquired. Acquiring pre-operative data atadjacent spinal levels provides quantitative functional baselineinformation at spinal adjacent levels which can be used to assess avariety of potential surgical processes. Post-operative changes atadjacent spinal levels are also evaluated to detect pre-symptomaticradiographic ALD. This allows the progression of radiographic ALD to bequantified over time. Based on the pre-operative and post-operativeinformation patient-specific recommendations can be made. Additionally,patient-directed interventions can be recommended to avoid or delay ALDprogression.

The systems and methods according to aspects of the disclosed subjectmatter may utilize a variety of computer and computing systems,communications devices, networks and/or digital/logic devices foroperation. Each may, in turn, be configurable to utilize a suitablecomputing device that can be manufactured with, loaded with and/or fetchfrom some storage device, and then execute, instructions that cause thecomputing device to perform a method according to aspects of thedisclosed subject matter.

A computing device can include without limitation a mobile user devicesuch as a mobile phone, a smart phone and a cellular phone, a personaldigital assistant (PDA), such as an iPhone®, a tablet, a laptop and thelike. In at least some configurations, a user can execute a browserapplication over a network, such as the Internet, to view and interactwith digital content, such as screen displays. A display includes, forexample, an interface that allows a visual presentation of data from acomputing device. Access could be over or partially over other forms ofcomputing and/or communications networks. A user may access a webbrowser, e.g., to provide access to applications and data and othercontent located on a website or a webpage of a website.

A suitable computing device may include a processor to perform logic andother computing operations, e.g., a stand-alone computer processing unit(CPU), or hard-wired logic as in a microcontroller, or a combination ofboth, and may execute instructions according to its operating system andthe instructions to perform the steps of the method, or elements of theprocess. The user's computing device may be part of a network ofcomputing devices and the methods of the disclosed subject matter may beperformed by different computing devices associated with the network,perhaps in different physical locations, cooperating or otherwiseinteracting to perform a disclosed method. For example, a user'sportable computing device may run an app alone or in conjunction with aremote computing device, such as a server on the Internet. For purposesof the present application, the term “computing device” includes any andall of the above discussed logic circuitry, communications devices anddigital processing capabilities or combinations of these.

Certain embodiments of the disclosed subject matter may be described forillustrative purposes as steps of a method that may be executed on acomputing device executing software, and illustrated, by way of exampleonly, as a block diagram of a process flow. Such may also be consideredas a software flow chart. Such block diagrams and like operationalillustrations of a method performed or the operation of a computingdevice and any combination of blocks in a block diagram, can illustrate,as examples, software program code/instructions that can be provided tothe computing device or at least abbreviated statements of thefunctionalities and operations performed by the computing device inexecuting the instructions. Some possible alternate implementation mayinvolve the function, functionalities and operations noted in the blocksof a block diagram occurring out of the order noted in the blockdiagram, including occurring simultaneously or nearly so, or in anotherorder or not occurring at all. Aspects of the disclosed subject mattermay be implemented in parallel or seriatim in hardware, firmware,software or any combination(s) of these, co-located or remotely located,at least in part, from each other, e.g., in arrays or networks ofcomputing devices, over interconnected networks, including the Internet,and the like.

The instructions may be stored on a suitable “machine readable medium”within a computing device or in communication with or otherwiseaccessible to the computing device. As used in the present application amachine readable medium is a tangible storage device and theinstructions are stored in a non-transitory way. At the same time,during operation, the instructions may at sometimes be transitory, e.g.,in transit from a remote storage device to a computing device over acommunication link. However, when the machine readable medium istangible and non-transitory, the instructions will be stored, for atleast some period of time, in a memory storage device, such as a randomaccess memory (RAM), read only memory (ROM), a magnetic or optical discstorage device, or the like, arrays and/or combinations of which mayform a local cache memory, e.g., residing on a processor integratedcircuit, a local main memory, e.g., housed within an enclosure for aprocessor of a computing device, a local electronic or disc hard drive,a remote storage location connected to a local server or a remote serveraccess over a network, or the like. When so stored, the software willconstitute a “machine readable medium,” that is both tangible and storesthe instructions in a non-transitory form. At a minimum, therefore, themachine readable medium storing instructions for execution on anassociated computing device will be “tangible” and “non-transitory” atthe time of execution of instructions by a processor of a computingdevice and when the instructions are being stored for subsequent accessby a computing device.

Additionally, a communication system of the disclosure comprises: asensor as disclosed; a server computer system; a measurement module onthe server computer system for permitting the transmission of ameasurement from a detection device over a network; at least one of anAPI (application program interface) engine connected to at least one ofthe detection device to create a message about the measurement andtransmit the message over an API integrated network to a recipienthaving a predetermined recipient user name, an SMS (short messageservice) engine connected to at least one of the system for detectingphysiological parameters and the detection device to create an SMSmessage about the measurement and transmit the SMS message over anetwork to a recipient device having a predetermined measurementrecipient telephone number, and an email engine connected to at leastone of the detection device to create an email message about themeasurement and transmit the email message over the network to arecipient email having a predetermined recipient email address.Communications capabilities also include the capability to communicateand display relevant performance information to the user, and supportboth ANT+ and Bluetooth Smart wireless communications. A storing moduleon the server computer system for storing the measurement in a detectiondevice server database can also be provided. In some systemconfigurations, the detection device is connectable to the servercomputer system over at least one of a mobile phone network and anInternet network, and a browser on the measurement recipient electronicdevice is used to retrieve an interface on the server computer system.In still other configurations, the system further comprising: aninterface on the server computer system, the interface being retrievableby an application on the mobile device. Additionally, the servercomputer system can be configured such that it is connectable over acellular phone network to receive a response from the measurementrecipient mobile device. The system can further comprise: a downloadableapplication residing on the measurement recipient mobile device, thedownloadable application transmitting the response and a measurementrecipient phone number ID over the cellular phone network to the servercomputer system, the server computer system utilizing the measurementrecipient phone number ID to associate the response with the SMSmeasurement. Additionally, the system can be configured to comprise: atransmissions module that transmits the measurement over a network otherthan the cellular phone SMS network to a measurement recipient usercomputer system, in parallel with the measurement that is sent over thecellular phone SMS network.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the invention. It should be understoodthat various alternatives to the embodiments of the invention describedherein may be employed in practicing the invention. It is intended thatthe following claims define the scope of the invention and that methodsand structures within the scope of these claims and their equivalents becovered thereby.

What is claimed is:
 1. A system for producing patient specificrecommendations for intervention, comprising a processor wherein theprocessor is configured to: receive two or more non-overlapping imagesof a spine; derive measurement data from the two or more non-overlappingimages of the spine wherein the measurement data is at least one ofspinal alignment, range of motion at target spine levels adjacent to aspinal fusion spine level measured across one or more spinalradiographic images; process the measurement data; calculate a risk ofan adjacent spinal level disease from the processed measurement data,and select an intervention from a list of interventions based on thecalculated measurement of risk.
 2. The system of claim 1 wherein thelist of interventions includes one or more patient self-directedinterventions.
 3. The system of claim 1 wherein the list ofinterventions includes interventions generated via a set of userconfigured variables that do not vary from patient to patient.
 4. Thesystem of claim 1 wherein the list of interventions includesinterventions selected to at least one of avoid and delay a progressionsof adjacent spinal level disease.
 5. The system of claim 1 wherein thelist of interventions includes one or more of: activity reduction,modification or substitution; weight loss; physical therapy focused oncore/neck strength; physical therapy focused on addressing pelvicanteversion or retroversion; and interventions to address functionalanomalies at adjacent levels.
 6. The system of claim 1 wherein thereceived two or more non-overlapping images of the spine is received ata single time point.
 7. The system of claim 1 wherein the image-derivedmeasurements include an analysis of a difference in measurements takenbetween two or more time points.
 8. Method of producing patient specificrecommendations for intervention comprising: receiving two or morenon-overlapping images of a spine; deriving measurement data from thetwo or more non-overlapping images of the spine wherein the measurementdata is at least one of spinal alignment, range of motion at targetspine levels adjacent to a spinal fusion spine level measured across oneor more spinal radiographic images; processing the measurement data;calculating a measurement of a risk of an adjacent spinal level diseasefrom the processed measurement data, and selecting an intervention froma list of interventions based on the calculated measurement of risk. 9.The method of claim 8 wherein the list of interventions includes one ormore patient self-directed interventions.
 10. The method of claim 8wherein the list of interventions includes interventions generated via aset of user configured variables that do not vary from patient topatient.
 11. The method of claim 8 wherein the list of interventionsincludes interventions selected to at least one of avoid and delay aprogressions of adjacent spinal level disease.
 12. The method of claim 8wherein the list of interventions includes one or more of: activityreduction, modification or substitution; weight loss; physical therapyfocused on core/neck strength; physical therapy focused on addressingpelvic anteversion or retroversion; and interventions to addressfunctional anomalies at adjacent levels.
 13. The method of claim 8wherein the received two or more non-overlapping images of the spine mayis received at a single time point.
 14. The method of claim 8 whereinthe measurements include an analysis of a difference in measurementstaken between two or more time points.